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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K892030
Device Name PATIENT EXAM GLOVES (MFG. TAN CHONG RUBBER GLOVES)
Applicant
Behn Meyer & Co. (M) Sdn Bhd
Resource Plz., 4 Lorong Persi
Barat, 46200 Petaling Jaya
Selangor Darul Ehsan,  MY
Applicant Contact KONG YIN
Correspondent
Behn Meyer & Co. (M) Sdn Bhd
Resource Plz., 4 Lorong Persi
Barat, 46200 Petaling Jaya
Selangor Darul Ehsan,  MY
Correspondent Contact KONG YIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/31/1989
Decision Date 05/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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